42 spine, orthopedic devices receive FDA 510(k) clearances in July 2016

Spinal Tech

The FDA granted 42 orthopedic- and spine-related device clearances in July.

1. The Progressive Orthopaedic Total Hip System from The Progressive Orthopaedic Company.

 

2. Genesys Spine Apache Anchored Cervical Interbody Fusion System from Genesys Spine.

 

3. Alta ACDF System from Biomet Spine.

 

4. Exactech GPS from Blue Ortho.

 

5. Savannah-T Pedicle Screw System from Amendia.

 

6. Belvedere Lateral Plating System from NeuroStructures.

 

7. MLX – Medial Lateral Expandable Lumbar Interbody System from NuVasive.

 

8. Stryker OrthoMap Express Knee System from Stryker.

 

9. Medinaut Kyphoplasty System from Imedicom.

 

10. PathLoc-C Posterior Cervical Fixation System from L&K Biomed.

 

11. Juliet Ti from Spineart.

 

12. Aesculap Implant Systems S4 Navigation Instruments from Aesculap Implant Systems.

 

13. Pro Fusion-V from NLT Spine.

 

14. Spinal Elements' Spinous Process Plate System from Spinal Elements.

 

15. Cure Anterior Cervical Plate System from Meditech Spine.

 

16. MectaLIF Anterior Stand-Alone from Medacta.

 

17. Keos Lumbar IBFD from Keos.

 

18. AccuLIF TL and PL Cage from Stryker.

 

19. CorticaLINK Spinal Fusion Platform from FacetLink DBA LinkSpine.

 

20. Intrafix Advance Tibial Fastener System from Medos International.

 

21. EasyStep from Stryker.

 

22. Integra External Fixation System from Ascension Orthopedics.

 

23. Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating from Cardinal Health.

 

24. Expedium Spine System, VIPER and VIPER 2 Systems from Medos International.

 

25. Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A Lumbar Interbody Fusion Device from Spineology.

 

26. DePuy Actis DuoFix Hip Prosthesis from DePuy.

 

27. Tritanium PL Cage from Stryker.

 

28. Dunamis Suture Anchor PEEK from Dunamis.

 

29. K2M Growing Spine System from K2M.

 

30. Conventus Orthopaedics Ulna Fixation System from Conventus Orthopaedics.

 

31. PASS OCT Spinal System from Medicrea.

 

32. Origin Coxa Vara Hip Stem from Signature Orthopaedics.

 

33. TransContinental M Spacers and InterContinental Plate-Spacers from Globus Medical.

 

34. Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System from Zimmer.

 

35. NuVasive VersaTie System from NuVasive.

 

36. Everest Spinal System from K2M.

 

37. Ascential IBD PEEK Spacer from Stryker Spine.

 

38. VertiForm Posterior Fixation System from Next OrthoSurgical.

 

39. Indigo Aspiration System from Penumbra.

 

40. PASS LP Spinal System form Medicrea.

 

41. ConforMIS iTotal Posterior Stabilized Knee Replacement System from ConforMIS.

 

42. Threshold Pedicular Fixation System from Spineology.

 

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